ProChondrix® CR Articular Cartilage Restoration Evaluation (PACE) Registry

NCT04301258 | Terminated

• 1 other identifier: REG-PRO-002
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 5

Brief Summary

The primary objective of this registry is to obtain long-term outcomes on ProChondrix CR in cartilage repair procedures of the knee, ankle, foot and hip.

Conditions

Cartilage Injury; Cartilage Damage

Keywords

Cartilage; Cartilage Injury; Cartilage Repair; Cartilage Damage; Cartilage Lesion; Cartilage Defect

Outcome Measures

Primary Outcomes (1)

• Long-Term Outcomes of ProChondrix CR

  Obtain long-term results on patients who have undergone an articular cartilage repair procedure using ProChondrix CR, as assessed by patient reported outcomes.

  10 Years Post-Operative

Study Arms (4)

Articular Cartilage Defect of the Knee

Patients, who undergo an articular cartilage repair of the knee using ProChondrix CR.

Other: Articular cartilage repair

Articular Cartilage Defect of the Ankle

Patients, who undergo an articular cartilage repair of the ankle using ProChondrix CR.

Other: Articular cartilage repair

Articular Cartilage Defect of the Foot

Patients, who undergo an articular cartilage repair of the foot using ProChondrix CR.

Other: Articular cartilage repair

Articular Cartilage Defect of the Hip

Patients, who undergo an articular cartilage repair of the hip using ProChondrix CR.

Other: Articular cartilage repair

Interventions

Articular cartilage repair OTHER

Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.

Also known as: ProChondrix CR

Articular Cartilage Defect of the Ankle; Articular Cartilage Defect of the Foot; Articular Cartilage Defect of the Hip; Articular Cartilage Defect of the Knee

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients, who diagnosed by their treating physician, have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention utilizing ProChondrix CR.

You may qualify if:

• Diagnosed by physician to have a cartilage defect in the knee, ankle, foot or hip that requires surgical intervention;
• Will be having, or has had, a cartilage repair procedure using ProChondrix CR;
• Has the ability to understand the requirements of the registry, to provide written informed consent and to comply with the registry protocol;

You may not qualify if:

• Is a ward of the state, prisoner, or transient.

Sponsors & Collaborators

• AlloSource: lead

Study Sites (5)

University of Southern Alabama

Mobile, Alabama, 36604, United States

Location

Rocky Mountain Foot and Ankle Center

Wheat Ridge, Colorado, 80033, United States

Location

CAO Research Foundation

Washington D.C., District of Columbia, 20037, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

Location

Beacon Orthopaedics & Sports Medicine

Cincinnati, Ohio, 45247, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: January 6, 2020
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)